AstraZeneca and Sanofi’s drug to prevent respiratory syncytial virus (RSV) has been given approval by a US regulatory panel, for use in infants, potentially adding to a group of breakthrough products that will reach pharmacy shelves this year.
The 21 advisers to the US Food and Drug Administration voted unanimously last Thursday to endorse the medicine for newborns and infants, calling the treatment’s safety profile compelling, reports TIME.
The long-acting monoclonal antibody called Beyfortus is designed to prevent the lung ailment in newborns and infants entering their first RSV season, which runs through the winter months. The drug is a single dose, which could boost uptake and real-world efficacy, committee members said.
The panel also voted to support the antibody’s use for children as old as two, who remain vulnerable to the disease through their second RSV season.
Sally Hunsberger, a committee member and biostatistician at the National Institutes of Health, said she voted a “weak no” because she wanted to ensure further research was done on the drug’s use in these populations, which includes those with congenital heart disease.
Recommendations from FDA advisory panels like the Antimicrobial Drugs Advisory Committee aren’t binding but are often followed by the agency. The drug is already approved for use in Britain, the European Union and Canada.
RSV is the leading cause of hospital admission for babies under the age of one, with most children contracting the disease before they are two-years-old.
Two vaccines for older people, from GSK and Pfizer, were approved by the FDA last month, and a maternal vaccine from Pfizer aimed at babies is expected to receive clearance this year.
Before the the recent breakthroughs, Astra had an older drug that was a passive immunisation for infants at risk of severe disease from RSV. However, the antibody provides only short-term protection and requires multiple injections.
TIME article – FDA advisers vote in favor of infant RSV drug (Open access)
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Pfizer’s RSV vaccine for older adults approved by FDA
FDA panel green-lights RSV pregnancy jab, but concerns persist
First RSV jab for adults approved by FDA